A Study To Assess The Efficacy And Safety Of Voriconazole In Chinese Patients With Serious Deep Tissue Fungal Infections

Pfizer

Status and phase: Completed; Phase 4

Conditions: Invasive Fungal Infections

Treatments: Drug: voriconazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT00288197

A1501066

Details and patient eligibility

About

To evaluate the efficacy and safety of voriconazole in Chinese patients with proven or probable deep tissue fungal infections.

Enrollment: 77 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subjects with proven or probable invasive fungal infections including subjects who have failed to respond to, or have an intolerance to other approved antifungal treatments and with approval for salvage treatment by Principal Investigator and Pfizer.

Exclusion criteria

• Subjects who are showing continuing improvement with other antifungal agents, including amphotericin B, itraconazole, nystatin, fluconazole, flucytosine and miconazole.
• Subjects with an invasive fungal infection caused by a fungus (such as Mucor) that is not in the antifungal spectrum of voriconazole.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)